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Characterizing the Placebo Response in Adults With ADHD.
Joseph Ben-Sheetrit1, Miriam Peskin1,2, Jeffrey H Newcorn3
1Geha Mental Health Center, Petah Tikva, Israel.
Journal of Attention Disorders
|June 22, 2018
Summary
High placebo response rates in adult ADHD trials are common. About half of these responses are inconsistent, complicating efficacy assessments in clinical studies.
Area of Science:
- Psychiatry
- Clinical Psychology
- Pharmacology
Background:
- Pharmacological trials for Attention-Deficit/Hyperactivity Disorder (ADHD) frequently report high placebo response (PR) rates.
- Understanding the characteristics of PR in adult ADHD is crucial for accurate trial interpretation.
Purpose of the Study:
- To characterize placebo response in adults diagnosed with ADHD.
- To investigate the temporal patterns and consistency of placebo response in this population.
Main Methods:
- Retrospective cohort analysis of 140 adult ADHD participants in the placebo arm of a 6-week clinical trial.
- Utilized Conners' Adult ADHD Rating Scale (CAARS) and Adult ADHD Self-Report Scale (ASRS) for assessment.
Main Results:
- Significant pre-post changes in both CAARS and ASRS scores were observed in placebo-treated adults.
- Less than half of participants exhibited early and persistent PR; nearly 50% showed variable, inconsistent PR.
- Placebo response was prominent on both self-report and investigator-rated scales.
Conclusions:
- Investigator ratings as a primary endpoint may not fully mitigate placebo response in adult ADHD trials.
- The variable nature of PR in approximately half of the participants suggests potential unreliability in determining treatment efficacy.
- Further research is needed to address the impact of variable placebo response on clinical trial outcomes.
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